Featured Trial

A Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Participants With Sjögren's (EnVISage)

Sponsor ID
417-201-00042
ClinicalTrials.gov Identifier:
NCT06928142
EudraCT ID
N/A
EUCTIS ID
N/A
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information:
N/A
Active, Not Recruiting
Sponsor ID
417-201-00042
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Trial Details
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Age
18 - 75 Years
Therapeutic Area
  • Sjögren's Disease
    • Sex
    Female & Male
    Trial Dates
    Apr 2025 - Mar 2027
    Healthy Volunteers
    No
    • Diagnosed with Sjögren's disease.
    • ESSDAI score (which measures disease activity) must be 5 or higher.
    • Salivary flow rate must be at least 0.05 mL/min.
    • Serum IgG level must be higher than 900 mg/dL.
    • Must be able to communicate well with the investigator and agree to follow the trial requirements.
    • Participants can continue certain medications (hydroxychloroquine, methotrexate, leflunomide, or azathioprine) if they have been on a stable dose for at least 30 days.
    • Corticosteroid dose must be stable and no more than 10 mg/day for at least 30 days.
    • Test positive for anti-Ro52 and/or anti-Ro60 antibodies.
    • Another active autoimmune rheumatic disease.
    • Prior use of B-cell depleting therapy or prohibited immunosuppressants.
    • Significant comorbidities including uncontrolled type 2 diabetes, malignancy, and chronic and/or acute infections.
    • Suicidal ideation or behavior based on the Patient Health Questionnaire-9 (PHQ-9).

    Trial Details

    This is a phase 2 study to evaluate the effects of sibeprenlimab (sye-be-PREN-li-mab) 400 mg administered subcutaneously (SC) (under the skin) every 4 (Q4) weeks or as an add-on in participants with Sjögren's disease.

    Additional Study Details

    Phase
    Phase 2
    Study Drug
    Biological: Sibeprenlimab
    Type
    Interventional
    Estimated Enrollment
    83
    Additional Study Details

    About Sjögren’s Disease

    Sjögren’s disease is estimated to be the second most common systemic autoimmune disease worldwide. Sjögren’s disease occurs when the immune system attacks the glands that produce tears and saliva, leading to gland damage which can cause dry eyes and dry mouth. Currently there are no approved therapies to modify Sjögren’s disease or progression, resulting in a high unmet need for the development of effective therapies.

    Otsuka Pharmaceutical Development & Commercialization, Inc (OPDC) is studying an investigational drug called sibeprenlimab. An investigational drug is a drug that is being studied for approval by the country specific regulatory body. This drug is not available for sale in the United States or in any other country. Sibeprenlimab is being studied as a possible treatment of Sjögren’s Disease.

    Trial Participation

    This study aims to:

    • Compare the effects of sibeprenlimab with a placebo.
    • See how sibeprenlimab affects your body by studying your biomarkers.
    • Determine if you make antibodies against sibeprenlimab.
    • Evaluate how your body processes sibeprenlimab by measuring drug levels in your blood.
    • This study will be run at approximately 50 study sites in up to 15 countries. About 80 participants who have Sjögren's disease and are between 18 to 75 years of age will take part in this study.
    • You will be in the study for approximately 68 weeks and must visit the study site approximately 19 times.
    • The first dosing period of this study is blinded, meaning neither you, the study doctor, or study staff will know which group you are assigned to. The blinding period lasts through week 24.
    • Following the blinded period, there will be an open-label period where no placebo is used and all participants will be given sibeprenlimab (study drug). If you choose to continue into the open-label you will get 7 doses of sibeprenlimab once every 4 weeks from 28 to Week 52.

    Inclusion and Exclusion Criteria

    Key Inclusion Criteria

    • Diagnosed with Sjögren’s Disease.
    • Test positive for anti-Ro52 and /or anti-Ro60 antibodies.
    • ESSDAI score (which measures disease activity) must be 5 or higher.
    • 18-75 years of age.

    Key Exclusion Criteria

    • Another active autoimmune rheumatic disease.
    • Prior use of B-cell depleting therapy or prohibited immunosuppressants.
    • Significant comorbidities including uncontrolled type 2 diabetes, malignancy, and chronic and/or acute infections.
    • Suicidal ideation or behavior based on the Patient Health Questionnaire-9 (PHQ-9)

    Requirements information
    Inclusion criteria
    • Diagnosed with Sjögren's disease.
    • ESSDAI score (which measures disease activity) must be 5 or higher.
    • Salivary flow rate must be at least 0.05 mL/min.
    • Serum IgG level must be higher than 900 mg/dL.
    • Must be able to communicate well with the investigator and agree to follow the trial requirements.
    • Participants can continue certain medications (hydroxychloroquine, methotrexate, leflunomide, or azathioprine) if they have been on a stable dose for at least 30 days.
    • Corticosteroid dose must be stable and no more than 10 mg/day for at least 30 days.
    • Test positive for anti-Ro52 and/or anti-Ro60 antibodies.
    Exclusion criteria
    • Another active autoimmune rheumatic disease.
    • Prior use of B-cell depleting therapy or prohibited immunosuppressants.
    • Significant comorbidities including uncontrolled type 2 diabetes, malignancy, and chronic and/or acute infections.
    • Suicidal ideation or behavior based on the Patient Health Questionnaire-9 (PHQ-9).

    Locations

    Location
    Status
    Location
    Medvin Clinical Research - Riverside
    Riverside, California, United States, 92508
    Status
    N/A
    Location
    Medvin Clinical Research - Tujunga
    Tujunga, California, United States, 91042
    Status
    N/A
    Location
    Bay Area Arthritis and Osteoporosis
    Brandon, Florida, United States, 33511
    Status
    N/A
    Location
    Clinical Research of West Florida Inc
    Clearwater, Florida, United States, 33765
    Status
    N/A
    Location
    GNP Research - Florida
    Cooper City, Florida, United States, 33024
    Status
    N/A
    Location
    Vantage Clinical Trials - Tampa - ClinEdge - PPDS
    Tampa, Florida, United States, 33606
    Status
    N/A
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